Regulatory Affairs Manager
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Job Location:
San Jose, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
Title: Regulatory Affairs Manager
Remote
USC or GC
Description:
- The Manager supports Global Reg Teams in the development and execution of global nonclinical / clinical regulatory strategies through a programs lifecycle.
- The Manager leads the execution of delegated activities including preparation for HA interactions and the preparation of regulatory submissions in support of the strategy.
KEY RESPONSIBILITIES:
- The RNC Manager responsibilities may vary depending upon product regulatory lifecycle and may include the leadership of selected activities which will be delegated by the Regulatory Nonclinical/ Clinical Lead and may include the following:
Development Stage Product
- Support the development of the nonclinical / clinical regulatory strategy and plan.
- Assist with selected planning document development and meeting execution activities in preparation for HA meetings / interactions.
- Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead.
- Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials.
- With oversight by RNC lead develop and coordinate the core nonclinical / clinical content of regulatory submissions.
- Responsible for ensuring high quality nonclinical/clinical content that adheres to regulations and guidances.
- Lead the maintenance of IND/CTAs throughout the life of the studies (e.g. annual reports)
- Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols Annual Reports Briefing Books etc.) and completing regulatory documents/forms for internal review.
- Collaborate with Reg PM to create and align submission timelines
- Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA.
- Oversee the collaboration of Nonclin/clin with Reg Ops to provide final documents and QC published outputs for submissions to HA.
- Organize and maintain the administrative nonclinical and clinical portions of INDs NDAs and BLAs.
- Oversee the archiving of HA submissions and correspondence
- Commercial Stage Product
- Lead the development of updates to the clinical and nonclinical sections of the core dossier used for INTL marketing applications.
- Provide support to RNC lead on development of nonclinical / clinical portions of required product lifecycle maintenance regulatory submissions examples are: clinical or nonclinical supplements to approved US product dossiers and any required annual reports license renewals supplemental filings.
- Coordinate necessary interactions with INTL in support of INTL MA filings. Examples include: meetings to provide RNC guidance/input on agency interaction submissions RTQs.
General - Attend relevant functional area and project team meetings.
- Review understand and stay up to date on regulations guidelines relevant to responsibilities
- Review documents (SOPs protocols and reports) related to Clinical or Nonclinical studies as necessary
- Ensure that the PM timelines and tracker accurately reflect submission plans
EDUCATION AND EXPERIENCE
Degree in health or life sciences including chemistry molecular biology or similar. PhD preferred Masters/Bachelors acceptable with relevant experience
Nonclinical / Clinical Regulatory Affairs experience preferred
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
